Kornimate/medical-research-clean huggingface dataset:
endothelial function, arterial stiffness and components

Conditions: Acute Lymphoblastic Leukemia

Summary: specific aim: compare the endothelial function, arterial stiffness and components of metabolic syndrome of childhood acute lymphoblastic leukemia (all) survivors to healthy sibling controls. plan: a cross sectional study comparing all survivors to sibling controls including measures of endothelial function and arterial stiffness obtained form a peripheral artery tonometry device, height, weight, waist circumference, fasting lipid, glucose and insulin.


Eligibility criteria:
inclusion criteria: survivor: inclusion 1. ages 8-28 (8 is chosen as lower age limit because developmental understanding will allow survivor to follow instructions for procedures, 28 is chosen as upper limit to include age ranges seen for treatment in the pediatric program) 2. off therapy for at least 6 months and not more than 10 years (6 months inclusion 1. biological sibling 2. ages 8-28 (when more than one sibling is available the one closest in age will be chosen.)) exclusion criteria: 1. uncontrolled medical conditions that could interfere with participation or interpretation of results 2. history of relapsed all or history of bone marrow transplantation

Keywords: acute lymphoblastic leukemia survivor sibling control
effect of proprietary botanical blend on glycemic control and post-prandial carbohydrate absorption

Conditions: Hyperglycemia; Carbohydrate; Insulin Resistance; Malabsorption

Summary: this project will test a unique botanical formula designed to inhibit alpha amylase (the primary starch degrading digestive enzyme) and inhibit sucrase (the primary sucrose degrading digestive enzyme) in order to reduce acute post prandial glycemia regardless of nutritive carbohydrate source.

type 2 diabetes is a metabolic disorder characterized by elevated fasting blood glucose and impaired insulin signaling (insulin resistance) and is associated with several comorbidities including neuropathy, retinopathy, kidney disease, and elevated risk for heart attack and stroke. lifestyle interventions targeted towards prevention of type 2 diabetes include: maintaining and achieving healthy bodyweight, physical activity, avoiding tobacco use, and reducing sugar and saturated fat intake. the international scientific consensus summit from the international carbohydrate quality consortium indicated that diets low in glycemic index and glycemic load were important in the prevention and management of diabetes. health supplements that can lower the glycemic index and glycemic load of food have potential to support the prevention of diabetes and improve blood glucose management by reducing post prandial glycemia and insulinemia. this project will test a unique botanical formula designed to inhibit alpha amylase (the primary starch degrading digestive enzyme) and inhibit sucrase (the primary sucrose degrading digestive enzyme) in order to reduce acute post prandial glycemia regardless of nutritive carbohydrate source. this proposal will fill a void in the literature by testing for the first time the effect of a combination of mulberry leaf, white kidney bean extract and cinnamon on postprandial carbohydrate absorption and glucose control in overweight, insulin resistant men and women. this project will provide pilot data to support larger studies, and studies to investigate long-term effects.

Eligibility criteria:
inclusion criteria: * ages 18-65 years * men and women * able to provide written consent in english * a body mass index between 23.0 and 30.0 kg/m2 * a fasting serum blood glucose level between 100.0 and 126.0 mg/dl exclusion criteria: * current smoker * having a bmi less than 23.0 kg/m2 and higher than 30.0 kg/m2 * having a fasting blood glucose level less than 100.0 mg/dl and higher than 126.0 mg/dl * suffering from known serious cardiac, hepatic, renal, pulmonary, gastrointestinal, endocrine or hematological disease based on investigator determination, aside from pre-diabetes * currently pregnant or breastfeeding * consuming more than 2 alcoholic drinks per day on average. * weight loss of more than 5% of body weight over the past 6 months

Keywords: glycemia carbohydrate blocker
a phase i study of qls12010 capsules in healthy adults

Conditions: Atopic Dermatitis; Hidradenitis Suppurativa (HS); Rheumatoid Arthritis (RA)

Summary: the goal of this clinical trial is to evaluate the safety, tolerability, pk, and pd of single and multiple ascending doses of qls12010 capsules and the effect of food on their pk profiles in healthy adult participants. this study consists of three parts: part a is a single ascending dose (sad) study, once sufficient safety and pk data are obtained from the sad cohorts, the smc will determine the dosage of initial cohort in part b, which consists of three multiple ascending doses (mad) cohorts of qls12010 capsules. part c is a randomized, open-label, two-cycle, crossover food effect study under fasting and fed (high-fat meal) conditions.


Eligibility criteria:
inclusion criteria: * males and females aged 18-45 (inclusive), * weight: ≥ 50 kg for males and ≥ 45 kg for females, body mass index (bmi): 18.0-30.0 kg/m2 (inclusive), exclusion criteria: * participants with diseases that should be excluded as judged by the investigator at screening, including but not limited to the nervous system, psychiatric system, cardiovascular system, blood and lymphatic system, immune system, respiratory system, digestive system, urinary system, metabolic and skeletal system disorders, * the 12-lead ecg at screening shows qtcf (qt corrected using fridericia's formula) \> 450 ms. if qtcf is \> 450 ms, the 12-lead ecg should be repeated 2 more times (at least 3 min apart), and the mean of the 3 measurements will be used to determine whether the participant meets the inclusion criteria, * participants who smoke more than 5 cigarettes per day on average within 6 months before screening or are currently using e-cigarettes, * participants who consume more than 14 units of alcohol per week (1 unit = 360 ml of beer, 45 ml of 40% spirits, or 150 ml of wine) within 6 months before screening or have a positive breath alcohol test at screening, * participants who have donated more than 400 ml of blood within 3 months or more than 200 ml of blood within 4 weeks before screening, or plan to donate blood during the study, * participants who have received any strong inhibitor or inducer of cyp3a4within 4 weeks before screening, * participants who have received any prescription drugs, otc drugs, traditional medicines, and dietary supplements within 2 weeks before the first dose or 5 half-lives (whichever is longer).
a clinical trial of prax-114 in participants with post-traumatic stress disorder

Conditions: Post-traumatic Stress Disorder; Post Traumatic Stress Disorder; Stress Disorder; Stress Disorders, Post-Traumatic; Trauma and Stressor Related Disorders; Mental Disorder

Summary: this trial is comprised of a 4-week randomized, double-blind, placebo-controlled treatment period followed by an optional 8-week open-label extension (ole) period. this trial will evaluate the efficacy and safety of oral prax-114 flexibly dosed at 40 to 60 mg for 4 weeks compared to placebo in adults with ptsd. the ole period consisting of treatment with 40 mg prax-114 for 8 weeks will provide additional efficacy and safety data.


Eligibility criteria:
inclusion criteria: 1. dsm-5 diagnosis of ptsd with duration \>6 months, as confirmed by psychiatric evaluation. 2. caps-5 total score ≥30 at screening and baseline. 3. body mass index (bmi) of 18 to 38 kg/m2. exclusion criteria: 1. experienced the index traumatic event before age 16. 2. has an active legal, worker's compensation, or disability claim for ptsd. 3. lifetime history of bipolar disorder, a psychotic disorder (eg, schizophrenia or schizoaffective disorder), or obsessive-compulsive disorder or a history of a psychotic mood episode in last 2 years. 4. ham-d17 score of \>18 at screening or baseline. 5. any current psychiatric disorder (other than ptsd). 6. lifetime history of seizures, including febrile seizures. 7. daily consumption of more than 2 standard alcohol-containing beverages for males or more than 1 standard alcohol-containing beverages for females.

Keywords: agents, gaba receptors, gaba-a allosteric regulation prax-114
study of letrozole plus tipifarnib or placebo in the treatment of advanced breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to determine if the addition of tipifarnib to standard letrozole therapy leads to a better response to treatment for your cancer in comparison to letrozole plus a placebo. tipifarnib belongs to a class of drugs called farnesyl transferase inhibitors (fti). it blocks proteins that make cancer cells grow.

this clinical study involves two groups of patients with advanced breast cancer. one group (2/3rds of all the patients) will be taking tipifarnib in combination with another anticancer drug called letrozole, and the other group (1/3rd of all the patients) will be taking letrozole plus a placebo (an inactive substance given in the same form as a real drug). the assignment to one of these two groups will be by chance (like flipping a coin). unless the need arises, neither the patient nor the study staff will know whether the patient is receiving tipifarnib with the letrozole. comparisons between the two groups will be made for patients who have achieve a confirmed complete response (cr) or partial response (pr). the interval between the date of randomization and the earliest date of disease progression will also be assessed. the study will include evaluations of safety and tolerability. patients should expect their participation in this trial to last a minimum of 4 to 8 weeks. their participation could continue for several months or beyond a year, depending on how their disease responds to the treatment. after completing study treatment, patients will be asked to attend for an end of treatment visit and then a posttreatment follow-up visit 4 to 6 weeks after stopping the medication. patients will be randomly assigned to treatment with either 2.5 mg letrozole once daily plus placebo to match tipifarnib twice daily, or 2.5 mg letrozole once daily plus 300 mg tipifarnib twice daily. both tipifranib and matching placebo will be given in 28-day cycles of 21 days of treatment followed by 7 days rest. all patients will receive continuous treatment with letrozole.

Eligibility criteria:
inclusion criteria: * locally advanced, inoperable loco-regionally-recurrent, or metastatic breast cancer * estrogen and/or progesterone positive disease * progression of disease after antiestrogen therapy * measurable disease * postmenopausal * eastern cooperative oncology group (ecog) performance status 0, 1, or 2. exclusion criteria: * previous endocrine therapy, other than antiestrogen therapy * more than 1 prior chemotherapy regimen * previous therapy with farnesyl transferase inhibitor * presence of rapidly progressive, life-threatening metastases * concomitant anticancer treatment * other malignancy within the past 5 years * symptomatic peripheral neuropathy.

Keywords: breast cancer zarnestra tipifarnib r115777 estrogen receptor positive progesterone receptor positive anti-estrogen therapy
transvaginal tape (tvt) secur versus tvt randomised controlled trial (rct)

Conditions: Urinary Incontinence, Stress

Summary: this randomized multi-centre trial will recruit women with stress urinary incontinence who need surgical treatment for their condition. 300 women will be allocated either to receive a tvt secur or a standard tvt surgical procedure. the main outcome is effectiveness of the procedure, determined using a 1-hour pad test (which tests for urine leakage) 12 months after surgery. the study will be carried out in 4 to 6 centers and will involve urogynaecologists, urologists and general obstetrician-gynaecologists: all clinicians will have received adequate training.


Eligibility criteria:
inclusion criteria: * women with stress incontinence, defined as leaking with increased abdominal pressure * eligible for both types of surgery exclusion criteria: women who: * have vaginal prolapse requiring surgical repair * have had previous incontinence surgery * have overactive bladder or incontinence is caused only by bladder overflow * intend to have further children * have alzheimer's or parkinson's disease, progressive neurological disease such as multiple sclerosis, or are immunocompromised * are unable to understand english * will be unavailable for follow-up
evaluation of the effect of an ankle foot orthoses for ambulatory function

Conditions: Hemiplegia, Spastic

Summary: the main purpose of this investigation is to evaluate the effect of a lower leg brace on walking efficiency and community walking in people who have weakness in one side of the body caused after a stroke. the evaluation will consist of several tests that will evaluate movement, tightness, balance and sensation in affected leg.

to comprehensively evaluate the effect of an afo on ambulatory function and loading in hemiplegic gait. this study is addressing important questions regarding the effect of an afo on gait and introduces technology for quantifiable objective assessment of afo effectiveness. it will attempt to identify if afo wear compliance increases community ambulation and walking efficiency bilaterally. research is needed to fully understand how compliance affects mobility outcomes.

Eligibility criteria:
inclusion criteria: * between the ages of 18 and 75 * have sustained a stroke at least 6 months prior to study enrollment * use a prescribed custom brace while walking * have no history of injury, orthopedic or other medical problem in the normal leg * be able to walk independently or with close supervision for 25 feet without a brace or cane * wear shoes sizes 5 1/2 - 11 us womens or size 6-13 us mens exclusion criteria: * orthopedic problems or history that will interfere with walking or limit the range of motion of legs * neurological illness, history, or conditions that my interfere with walking except for stroke * psychiatric conditions or history that would interfere with the ability to walk or follow directions * serious lung or heart condition that could severely limit the ability to walk

Keywords: stroke hemiplegia afo gait
microfinance institutions as a platform for global health

Conditions: Malnutrition; Anemia

Summary: this study will analyze data from a program run by an microfinance institution (mfi) in haiti from 2011-2012 where the mfi delivered health goods to some of the villages where it operates. by comparing health indicators among children who were in villages targeted by the program initially to children who were in villages that were not targeted by the program until later, the investigators hope to understand if the mfi successfully delivered the intervention and offer a practical platform for delivery of basic health goods.

two-thirds of child deaths could be prevented with increased coverage of existing health products and services; however, effectively delivering health products and services to rural populations in low-income countries remains a practical challenge. this study investigates whether microfinance institutions (mfis), having invested in community-based infrastructure to deliver financial services to 200 million rural poor households globally, offer a practical platform for delivery of basic health goods. the investigators intend to analyze data from a pilot program implemented by an mfi in haiti during 2011-2012 that distributed an evidence-based health good, micronutrient powders (mnps), to 526 children in 34 villages where the mfi operates. micronutrient deficiency is estimated to be responsible for over 1 million deaths of children under five per year. mnps are one form of micronutrient supplementation proven to effectively combat micronutrient deficiency. published cost estimates indicate that leveraging existing supply chains could cut the total cost of mass mnp delivery by 25%. given mfis reach 200 million households globally, mfi-based delivery of health goods may be a promising route to improving health outcomes efficiently.

Eligibility criteria:
inclusion criteria: * lives in a household where the head of household was an microfinance client. exclusion criteria: * severely anemic (hgb \< 70 g/l) * severely malnourished (mid upper arm circumference \< 110 mm)

Keywords: microfinance institution mfi
nab-paclitaxel plus s-1 in patients with advanced pancreatic cancer

Conditions: Advanced Pancreatic Cancer

Summary: the purpose of this study is to determine the efficacy and safety of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) plus s-1 as first-line treatment in chinese patients with advanced pancreatic ductal adenocarcinoma (pda).

advanced pda is a lethal disease with a approximately 6 months of median survival. gemcitabine is always the only approved single agent. the recent results of the phase iii trial mpact (metastatic pancreatic adenocarcinoma clinical trial) demonstrated an improvement in overall response rate (orr), progression free survival (pfs) and overall survival (os) for the combination of nab-paclitaxel plus gemcitabine compared to gemcitabine alone. thus, the combination of nab-paclitaxel with gemcitabine became one of a standard treatment in metastatic pda. s-1 is an oral fluoropyrimidine, and shown to be non-inferior to gemcitabine on os for unresectable pancreatic cancer, and also demonstrated non-inferior, and even superior to gemcitabine as adjuvant chemotherapy. this single-arm study is to explore the efficacy and safety of nab-paclitaxel plus s-1 as first-line treatment in chinese patients with local advanced or metastatic pancreatic ductal adenocarcinoma.

Eligibility criteria:
inclusion criteria: 1. signed informed-consent form. 2. age no less than 18 years. 3. histologically confirmed locally advanced or metastatic pancreatic ductal adenocarcinoma, with recist measurable lesions. 4. eastern cooperative oncology group (ecog) 0-1 with life expectation of no less than 12 weeks. 5. patients must have received no previous chemotherapy or investigational therapy for the treatment of metastatic disease. prior treatment with 5-fluorouracil or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present. 6. adequate liver/bone marrow function. 7. human chorionic gonadotropin (hcg) test negative for female with contraception measure until 3 months after study end. 8. compliant, and can be followed up regularly. exclusion criteria: 1. pregnant or breast-feeding female, or not willing to take contraception measures during study. 2. serious infection requiring antibiotics intervention during recruitment. 3. allergic to study drug. 4. more than grade 1 neuropathy. 5. uncontrolled brain metastasis or mental illness. 6. congestive heart failure, uncontrolled cardiac arrhythmia, etc. 7. other malignancy within 5 years. 8. can't be followed up or obey protocol. 9. ineligible by the discretion of the investigator.

Keywords: nanoparticle albumin-bound paclitaxel s-1 advanced pancreatic cancer objective response rate
a study of tocilizumab in combination with dmards in patients with moderate to severe rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this 2-arm study assessed the safety and efficacy of tocilizumab versus placebo, both in combination with disease modifying antirheumatic drugs (dmards), in regard to reduction in signs and symptoms, in patients with moderate to severe active rheumatoid arthritis with an inadequate response to dmards. patients were randomized in a ratio of 2:1 to receive either tocilizumab 8 mg/kg intravenously (iv) or placebo iv every 4 weeks. all patients also received stable antirheumatic therapy, including permitted dmards. the anticipated time on study treatment was 3-12 months and the target sample size was 500+ individuals.


Eligibility criteria:
inclusion criteria: * adult patients, ≥18 years of age * active rheumatoid arthritis of \>6 months duration * received permitted dmards each at a stable dose for at least 7 weeks prior to baseline exclusion criteria: * rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis * major surgery within 8 weeks prior to screening or planned within 6 months following randomization * unsuccessful treatment with a biologic agent, including an anti-tnf agent * previous treatment with tocilizumab
vandetanib and radiation therapy in treating young patients with newly diagnosed diffuse brainstem glioma

Conditions: Brain and Central Nervous System Tumors

Summary: this phase i trial is studying the side effects and best dose of vandetanib when given together with radiation therapy in treating young patients with newly diagnosed diffuse brain stem glioma.

vandetanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. giving vandetanib together with radiation therapy may kill more tumor cells. patients undergo conformal radiotherapy once daily, 5 days a week, for 6 weeks. patients also receive oral vandetanib once daily beginning on the same day as radiotherapy and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity. cohorts of 3-6 patients receive escalating doses of vandetanib until the maximum tolerated dose (mtd) is determined. blood samples are collected periodically for pharmacokinetic studies, polymorphism analysis (e.g., cyp3a4/5), and immunological laboratory methods (e.g., western blot assay). imaging studies are also conducted periodically.

Eligibility criteria:
* diagnosis of 1 of the following: * diffuse brainstem glioma * high-grade glioma originating from brainstem * age must be greater than or equal to 2 years and less than 21 years * newly diagnosed disease * lansky or karnofsky performance status 40-100% * anc ≥ 1,000/mm³ * platelet count ≥ 100,000/mm³ (transfusion independent) * hemoglobin ≥ 8 g/dl (transfusion allowed) * bilirubin \< 1.5 times upper limit of normal (uln) for age * alt \< 5 times uln * albumin ≥ 2 g/dl * creatinine \ 70 ml/min * qtc interval \< 450 msec by ekg * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception

Keywords: untreated childhood brain stem glioma
descriptive observational study alk-2016-cphg

Conditions: NSCLC; Crizotinib; ALK Gene Rearrangement or ROS1 Gene Rearrangement

Summary: descriptive observational study. characteristics of alk-positive and ros1-positive adults patients non-small cell lung cancer (nsclc) treated with crizotinib within general hospitals

describe the characteristics of patients treated with crizotinib describe efficacy, safety, observance and qol.

Eligibility criteria:
inclusion criteria * age ≥ 18 years * locally advanced or metastatic nsclc * patient alk gene rearrangement or ros1 gene rearrangement * patient having initiated in the previous 3 months or patient initiating crizotinib treatment regardless of the line of treatment * patient followed up by a physician in a hospital pulmonary medicine department * subject of reproductive age, using an effective method of contraception * patient informed verbally and in writing on the study and having consented to his/her personal data being collected within the scope of the study. non-inclusion criteria * patient included within the scope of an interventional therapeutic trial * patient not presenting with alk gene rearrangement or ros1 gene rearrangement * patient not available for follow-up throughout the duration of the study * patient deemed to be incapable of responding to the study questions for linguistic, cognitive or organisational reasons.

Keywords: non-small cell lung cancer (nsclc) crizotinib alk gene rearrangement or ros1 gene rearrangement